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1 1 Teasdale, A. and Elder, D.E. (2015). Is avoidance of genotoxic intermediates/impurities tenable for complex, multistep syntheses? Org. Process Res. Dev. 19: 1437–1446.

2 2 Jacobson‐Cram, D. and McGovern, T. (2007). Toxicological overview of impurities in pharmaceutical products. Adv. Drug Deliv. Rev. 59: 38–42.

3 3 Dobo, K.L., Greene, N., Cyr, M.O. et al. (2006). The application of structure based assessment to support safety and chemistry diligence to manage mutagenic impurities in actives pharmaceutical ingredients during drug development. Regul. Toxicol. Pharmacol.44: 282–293.

4 4 Pierson, D.A., Olsen, B.A., Robbins, D.K. et al. (2009). Approaches to assessment, testing decisions and analytical determination of mutagenic impurities in drug substances. Org. Process Res. Dev. 13 (2): 285–291.

5 5 Ames, B.N., Durston, W.E., Yamasaki, E.E., and Lee, F.D. (1973). Carcinogens and mutagens: a simple system combining liver homogenates for activation and bacteria for detection. Proc. Nat. Acad. Sci. USA 72: 2423–2427.

6 6 ICH Q8 (R2). Pharmaceutical Development. http://www.emea.europa.eu/pdfs/human/ich/51881907enfin.pdf (accessed September 2020).

7 7 ICH Q9. Quality Risk Management. http://www.emea.europa.eu/Inspections/docs/ICHQ9Step4QRM.pdf (accessed September 2020).

8 8 ICH Guideline M7 (R1). On Assessment and Control of DNA Reactive (mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk.

9 9 ICH Q3a (R2). Impurities in New Drug Substances (Revised Guideline). CPMP/ICH/2737/99.

10 10 ICH Q3B (R2). Impurities in New Drug products (Revised Guideline). CPMP/ICH/2738/99.

11 11 Harvey J. A, Fleetwood A, Ogilvie R, Teasdale A, Wilcox A.P and Spanhaak S; Management of organic impurities in small molecule medicinal products: deriving safe limits for use in early development Reg. Tox. Pharmacol.; 2017, 84, 116 to 123.

12 12 Müller, L., Mauthe, R.J., Riley, C.M. et al. (2006). A rationale for determining, testing and controlling specific impurities in pharmaceuticals that possess potential for mutagenicity. Regul. Toxicol. Pharmacol. 44: 198–211.

13 13 Bercu, J., Galloway, S.M., Parris, P. et al. (2018). Potential impurities in drug substances: compound‐specific toxicology limits for 20 synthetic reagents and by‐products, and a class‐specific toxicology limit for alkyl bromides. Regul. Toxicol. Pharmacol. 94: 172–182.

14 14 Teasdale, A., Fenner, S., Ray, A. et al. (2010). A tool for the semiquantitative assessment of potentially genotoxic impurity (PGI) carryover into API using physicochemical parameters and process conditions. Org. Process Res. Dev. 14: 943–945.

15 15 Teasdale, A., Elder, D., Chang, S.‐J. et al. (2013). Risk assessment of genotoxic impurities in new chemical entities: strategies to demonstrate control. Org. Process Res. Dev. 17: 221–−230.

16 16 Elder, D.P., Okafo, G., and McGuire, M. (2013). Assessment of predictivity of semiquantitative risk assessment tool: pazopanib hydrochloride genotoxic impurities. Org. Process Res. Dev. 17: 1036–1041.

17 17 McLaughlin, M., Dermenijan, R.K., Jin, Y. et al. (2015). Evaluation and control of mutagenic impurities in a development compound: purge factor estimates vs measured amounts. Org. Process Res. Dev. 19: 1531–1535.

18 18 Lapanja, N., Zupančič, B., Toplak Časar, R. et al. (2015). A generic industry approach to demonstrate efficient purification of potential mutagenic impurities in the synthesis of drug substances. Org. Process Res. Dev. 19: 1524–1530.

19 19 Barber, C., Antonucci, V., Baumann, J.‐C. et al. (2017). A consortium‐driven framework to guide the implementation of ICH M7 option 4 control strategies. Regul. Toxicol. Pharmacol. 90: 22–28.

20 20 ICH guideline S9 on nonclinical evaluation for anticancer pharmaceuticals. EMA/CHMP/ICH/646107/2008.

21 21 Boyer T, Choudary B.M, Edwards A.J, et al.; Development of a scalable process for the PPAR‐α agonist GW6415 7X incorporating Baeyer−Villiger chemistry and retrospective ICH M7 assessment Org. Proc. Res. Dev.; 2020, 16 (12), 1927 to 1939.

22 22 Derek v6.0 (KB 2018v1.1), Lhasa Ltd.

23 23 Leadscope v2.2.1 (Salmonella V3, E.Coli‐TA102 V1), Leadscope Inc.

24 24 Sartan medicines: companies to review manufacturing processes to avoid presence of nitrosamine impurities. https://www.ema.europa.eu/en/documents/referral/valsartan‐article‐31‐referral‐sartan‐medicinescompanies‐review‐manufacturing‐processes‐avoid_en.pdf (accessed September 2020).